25 November 2016
ISPE Turkey Affiliates 2016 Fall Seminar was held on 25 November 2016 at Barbaros Point Hotel Istanbul with the theme of A Journey to the Pharmaceutical Facilities of the Future with the Vision of Industry 4.0.
The seminar started with opening remarks of Fatma Taman, Chair of ISPE Turkey Affiliate, and continued with "GMP Updates in the PIC/S Compliance Process" presentation of MSc. Pharm. Gülşen Yılmaz from the Inspection Vice Presidency of Turkish Medicines and Medical Devices Agency (TMMDA) who elaborated on TMMDAs studies with regards to PIC/S membership application process.
Siemens Digital Factory Country Division Lead Ali Rıza Ersoy presented the concept of Industry 4.0 which was very well received by the audiance and Nejat Babür, Anel Group Mechanical Design Coordinator, shared his experience and knowledge via his presentation on the facilities of the future and new approaches for facility design.
The afternoon session of the seminar included Ecolab Life Sciences Unit Middle East Africa Manager Burcu Şekers presentation about Cleaning and Contamination Control in the Facilities of Future and Deloitte Health and Pharmaceutical Industry Leader Güler Hülya Yılmazs presentation on Health and Pharmaceutical Sector Predictions for the year of 2020.
The seminar was concluded with an interactive panel session where sectoral topics like biotechnology, PIC/S process, R&D studies were discussed with the contributions of Chair of Pharmaceutical Industry Association of Turkey (TISD) Cengiz Celayir, Secretary General of Pharmaceutical Manufacturers Association of Turkey (İEİS) Turgut Tokgöz and Secretary General of Association of Research-Based Pharmaceutical Companies (AİFD) Dr. Ümit Dereli.
Chair of ISPE Turkey Affiliate Fatma Tamans article titled as Operational Excellence from ISPEs Perspective has been published in the 50th Special Issue of the Workshop Magazine.
Fatma Taman emphasized that operational excellence is a roof concept that aims doing more with less, taking into account all operational processes and integrating values including health and safety, environment and quality. From the perspective of the pharmaceutical industry which is based on advanced technology that needs to adapt scientific and technological developments rapidly, but on the other hand, can not compromise in quality, coupled with the fact that saving policies in pharmaceutical spending are an important matter in the agenda of public authorities, Ms. Taman pointed out that the improvements in the pharmaceutical sector are even more sensitive and important.
Fatma Taman referred to ISPE Turkey Affiliates seminars organized in order to enable the Turkish pharmaceutical industry to closely monitor the changes in the global platform via worldwide experts that contribute as speakers; also mentioned PAT (Process Analytical Technologies) working group which deals with the QbD (Quality by Design) topic that has a wide range of potential applications in the pharmaceutical industry and the PQLI (Product Quality Life Cycle Application) approach that aims to integrate quality into the whole lifecycle of the product and emphasized the great importance of all these activities in the context of Operational Excellence.
It was indicated that the topic of Operational Excellence will be discussed in the future Industry Gatherings planned by ISPE Turkey Affiliate as afternoon meetings which are enriched by experience sharing of speakers coming from different sectors, after having discussed current topics such as Data Integrity and Industry 4.0 so far. Further studies are also planned to be continued within the Excellence in Pharma Engineering Working Group which will be founded in 2017.
A Journey to the Pharmaceutical Facilities of the Future with the Vision of Industry 4.0
25 November 2016
ISPE Turkey Affiliates 2016 Fall Seminar will be held on 25 November 2016 at Barbaros Point Hotel Istanbul around the theme of Journey to the Pharmaceutical Facilities of the Future with the Vision of Industry 4.0.
The concept of Industry 4.0 and 2020 predictions for the Health-Pharmaceutical Sector will be presented. Design and Contamination Approaches for Pharmaceutical and Biotechnological Facilities of the Future will also be discussed in conjunction with these developments.
Some of the speakers:
We hope for your participation to this important seminar focused on creating the vision for the future.
The detailed program (in Turkish) will be presented later.
Third International Congress for Plastic Packaging Technologies was organized a day before Eurasia Packaging Fair, on 1st of November 2016 in Istanbul by PAGEV (Turkish Plastic Industry Foundation).
At this year's congress created with the supports of ISPE Turkey Affiliate, plastic packaging used in the pharmaceutical and cosmetic sectors was taken under the spotlight in conjunction with the congress theme of Innovative Packaging Trends and Branding. As a speaker, Our General Secretary Buket Hekiman Bayraktar has contributed to the pharmaceutical panel of the congress where topics such as new technologies, innovative developments, sustainability, design and branding were discussed.
The 1st International JFDA Congress, hosted by the Jordanian Health Authority was held in Amman - Jordan on October 27-28, 2016 around the theme of "Opportunities and Future Vision for Pharmaceutical Sector. Including Dr. Hakkı Gürsöz, the President of Turkish Medicines and Medical Devices Agency (TMMDA) and Dr. Ali Alkan, TMMDA Vice Presidency of Medicines and Pharmacy, high-order bureaucrats and health authority executives from neighboring countries have extensively participated to the congress, where Chair of ISPE Turkey Affiliate Fatma Taman had a presentation on "Risk Mitigation for Sterile Pharmaceutical Products".
18 October 2016
The second of Industry Gatherings that ISPE Turkey Affiliate organizes as afternoon meetings based on the current issues, was held on 18 October 2016 at The Grand Tarabya and covered the topic of Industry 4.0.
Following opening remarks of our Chair Fatma Taman, Tolga Avşar - General Manager of Scheer Turkey presented the expected changes for business life in the near future with an emphasis on the upcoming 4th industrial revolution called "Industry 4.0". The meeting continued with the speech of Ali Rıza Ersoy - Digital Factory Division Director of Siemens and he elaborated on the Industry 4.0 concept based on his knowledge and experiences that were well received by the audience.
We thank all participants and wish to meet in future Industry Gatherings which are aimed at addressing various current issues concerning the pharmaceutical industry.
The second workshop of Data Integrity Key for GMP Compliance working group founded in 2016 within the ISPE Turkey Affiliate was held on October 14, 2016 at the facilities of Nobel İlaç Tic. ve San. A.Ş. Ümraniye with broad participation from the pharmaceutical industry.
The workshop started with opening remarks of Hakan Şahin, General Manager of Nobel Pharmaceuticals, and the presentations of Our Chair Fatma Taman and Ulkar Holdings Corporate Quality Manager Aysel Köker; then continued with our working group leader Figen Ergins presentation about Authority warning letters in connection with data integrity issues and group studies under the topics of quality control, quality assurance, production / storage and validation were performed as preliminary work towards a risk inventory.
We thank Nobel Pharmaceuticals and all our participants for their contributions and wish to meet in future workshops and seminars.
Industry Gathering: Industry 4.0
18 October 2016
The second of Industry Gatherings that ISPE Turkey Affiliate organizes as afternoon meetings based on the current issues, will be held on 18 October 2016 at The Grand Tarabya and will cover the topic of Industry 4.0.
We wish to be together at our meeting which will provide a knowledge sharing platform for "Industry 4.0" concept based on the presentations of our esteemed speakers, Tolga Avsar - General Manager of Scheer Turkey and Ali Rıza Ersoy - Deputy General Manager for Digital Factory Division of Siemens.
Date: October 18, 2016 - Tuesday
Location: The Grand Tarabya - Tarabya Hall
The premier pharmaceutical manufacturing event of the year, ISPE Annual Meeting was held on 18-21 September 2016 in Atlanta, USA. The Turkey Affiliate was represented by our Chair Fatma Taman, Affiliates Secretary General Buket Hekiman Bayraktar and Reserved Member of the Board Banu Refik. In the awards ceremony on September 20, our Affiliate was honoured by receiving the "Affiliate of the Year Award for the service to membership and innovative contributions towards the development of the pharmaceutical industry.
The award given by Joseph Famulare, the Chairman of ISPE International Board for 2015-2016 and Michael Arnold the Chairman for 2016-2017 was received by our Chair Fatma Taman on behalf of our Affiliate, which recently celebrated its 10th year anniversary in 2015. Fatma Taman expressed our pride for getting this award for the second time after the first Affiliate of the Year Award that we got in 2007, only 2 years after the foundation of our Affiliate.
This important recognition achieved one more time should enhance Turkey's credibility in the global pharmaceutical platform. We are grateful to our Board and all our members for their individual contributions toward this success.
October 14, 2016
The second workshop of ISPE Turkey Data Integrity Key for GMP Compliance working group will be held on October 14, 2016 at the facilities of Nobel İlaç Tic. ve San. A.Ş. Ümraniye.
We wish to be together at our workshop where group studies about the risk inventory and authority warning letters with regards to data integrity matters will be conducted.
CPhI Istanbul and its co-located events that gathered regional drug manufacturers, suppliers, solution and technology providers was held on 1 - 3 June 2016 at Istanbul Congress Center, ICC, Turkey.
The visitors were informed about the objectives, working groups and events of ISPE Turkey Affiliate via the booth that was set up at the exhibition which gathered participants from abroad, science and technology experts, government delegates and major players of the pharmaceutical sector.
The General Assembly of ISPE Turkey Affiliate was held on 4 May 2016. Following the presentation of the annual report for 2014-2015, financial statements and report of the supervisory board; the estimated budget for 2016 was conferred.
The new Board, as decided to consist of 14 people , was elected for 2 years of tenure: Fatma Taman (PharmaVision), Sabiha Buket Hekiman Bayraktar (PharmaVision), Sabine İlknur Gümüşeli Hırçın (Bayer), Havva Çınar Aşar (Bayer), Neşe Buket Aksu (İstanbul Kemerburgaz University), Ayla Deliorman (Santa Farma) and Devrim Çavuşoğlu (Pfizer) were elected as Principal Members and Fahrettin Kazak (PharmaVision), Tanju Cepheli (BASF), Zafer Öztuncer (Merck), Figen Ergin (BTS), Hülya Uslu, Yıldız Özsoy Erginer (İstanbul University), Banu Refik (Conval Group) were elected as Reserved Members.
We welcome the members of Board and wish to leave our mark on further achievements together.
ISPE International Board!
24-25 October 2016, Industriepark Höchst, Frankfurt, Germany
ISPE Europe Conference on Biotechnology will be held on 24-25 October 2016 at the Sanofi plant in Frankfurt, Germany.
The conference which promises collaborative networking with the best industry professionals through case studies, presentations, panel discussion and the opportunity to participate in a Sanofi Plant Tour will focus on revisiting the bio-manufacturing approach and perspective through the core areas of Regulatory and Quality, Knowledge Management, Process Science, Technology and Innovation.
For more information and registration: http://www.ispe.org/2016-europe-biotechnology-conference
Data Integrity Key for GMP Compliance Workshop
26 May 2016
The first workshop of our "Data Integrity Key for GMP Compliance" working group founded in 2016 within the ISPE Turkey Affiliate, was held in May 26, 2016 at Gebze 1 facility of Sandoz.
Following opening remarks of Sandoz Gebze 1 Site Lead Şafak Öner and our Chair Fatma Taman; general titles referred at Data Integrity Industry Gathering that was held on March 21, 2016 at The Grand Tarabya were discussed in details; several FDA warning letters were reviewed via the interactive presentations of Figen Ergin, the leader of our working group.
Gülbengü Kuzgun Yüksel, Quality Unit Manager of Sandoz Gebze 1 gave substantial information via the presentation where she shared her experiences on data integrity based on the studies conducted on their site.
We hope to be together at our events that will be held on the continuation of the highly productive workshop where sectoral discussions were made on "Data Integrity" topic with the contributions of all participants.
CPhI Istanbul and its co-located events which will gather regional drug manufacturers, suppliers, solution and technology providers during 3 days will be held on 1 - 3 June 2016 at Istanbul Congress Center, ICC, Turkey.
You are invited to ISPE Turkey Affiliate booth on the B5 floor of the exhibition that will bring together science and technology experts, government delegates and major players of the pharmaceutical sector (Booth no:F39D).
For more information about the exhibition and conference: www.cphi-istanbul.com
Data Integrity Key for GMP Compliance Workshop
26 May 2016
The first workshop of our "Data Integrity Key for GMP Compliance" working group, founded in 2016 within the ISPE Turkey Affiliate, will be held in May 26, 2016 at Gebze 1 facility of Sandoz.
General titles referred at Data Integrity Industry Gathering that was held on March 21, 2016 at The Grand Tarabya, will be discussed in details; several FDA warning letters will be reviewed and delegates from Sandoz will elaborate on data integrity studies conducted on the site.
We wish to be together at our workshop where Data Integrity topics will be evaluated on a sectoral basis.
The first workshop of our "Quality & Metrics working group, founded within the ISPE Turkey Affiliate in 2016 and leaded by İlknur Gümüşeli Hırçın, was held in May 4, 2016 at Topkapı facility of Bayer Turkey.
Following the General Assembly of ISPE Turkey Affiliate, the workshop was initiated with opening remarks of our Chair Fatma Taman and Board Member İlknur Gümüşeli Hırçın. Discussions around "Quality Metrics" concept, practices and challenges in this regard were covered via the detailed Requirements and Assessment of Quality Metrics presentation of our Board Member Havva Çınar Aşar.
We hope to be together in workshops and seminars that will be planned as sequels of our interactive workshop where sectoral discussions and assessments were made on "Quality Metrics" studies.
ISPE Turkey Affiliate's Spring Seminar on Good Distribution Practices for APIs, Pharmaceuticals and Biopharmaceuticals" was held on 15 April 2016, at Barbaros Point Hotel, Istanbul.
The seminar which brought together participants from various areas such as pharmaceutical industry, suppliers, and academy, opening remarks of our Chair Fatma Taman were followed by ISPE's Vice President for European Operations Dr. Thomas Zimmers presentation on the ongoing studies for ensuring the continuity of drug supply.
GDP implementations for pharmaceutical and biological products were explained by Khalid Alfhaid, International Quality Senior Manager from Amgen and real-life examples on GDPs were presented by Zafer Öztuncer, Intercontinental Quality Assurance Director from Merck Pharmaceuticals.
On the afternoon session of the seminar, Jean-Marie Higel, Head of Service Quality in Global Services at BASF presented Good Distribution Practices for APIs and Deva Holding Logistics Manager Gürcan Coşgun elaborated on the transportation requirements in the scope of GDP. The seminar was concluded with an interactive panel session where GDP topics were discussed at a wide range with the contributions of the speakers and participants.
Our Affiliate Chair Ms. Fatma Taman made a presentation with the title of "ISPE Turkeys Perspective on Evolving Regulations and Facilities of the Future on Thursday, April 21, 2016 at Cleanroom Technology, Maintenance and Equipment Exhibition organized on 21-23 April 2016 in ICEC Lütfi Kırdar International Congress and Exhibition Center, İstanbul.
Following a quick overview of ISPE Turkey Affiliates recent accomplishments, hot topics that will soon impact the pharmaceutical industry both on a national and international level such as Industry 4.0, GMP revisions, future-proof facilities were covered and were followed with great interest by the representatives of health, medicine and chemical sectors as well as pharmaceutical and biotechnology industry experts.
The visitors were informed about the objectives, training programs, working groups and global events of ISPE Turkey Affiliate via the booth that was set up at the exhibition which gathered cleanroom specialists and managers, laboratory assistants, facilities and process managers, maintenance engineers, quality control experts and R&D managers.
For more information about the exhibition: http://www.expocleanroom.com/default.asp
Quality & Metrics Workshop
May 4, 2016
The first workshop of our "Quality & Metrics working group, founded in 2016 within the ISPE Turkey Affiliate, will be held in May 4, 2016 at Topkapı facility of Bayer Türk.
The workshop will begin following the General Assembly of ISPE Turkey Affiliate and will cover discussions around "Quality Metrics" concept, practices and challenges in this regard.
We wish to be together at our workshop where studies on "Quality Metrics" will be assessed and evaluated on a sectoral basis.
Good Distribution Practices for APIs,
Pharmaceuticals and Biopharmaceuticals
15 April 2016
ISPE Turkey Affiliate's Spring Seminar on Good Distribution Practices for APIs, Pharmaceuticals and Biopharmaceuticals" will be held on 15 April 2016, at Barbaros Point Hotel, Istanbul.
Studies for ensuring the continuity of drug supply will be presented by ISPE's Vice President for European Operations Dr. Thomas Zimmer, GDP applications for pharmaceutical and biological products will be explained by International Quality Senior Manager Khalid Alfhaid from Amgen Inc. and Intercontinental Quality Assurance Director Zafer Öztuncer from Merck Pharmaceuticals will relay information about cold chain practices for pharmaceutical and biopharmaceutical products. Following the presentation on GDP practices for APIs by Jean-Marie Higel, Head of Service Quality in Global Services at BASF; Deva Holding Logistics Manager Gürcan Coşgun will elaborate on the transportation requirements in the scope of GDP.
We look forward to your attendance to this important seminar which will cover the regulations about the storage and distribution practices for active ingredients, pharmaceuticals and biopharmaceuticals.
Participation Fee: For Members: 900 TL, For Non-Members: 1500 TL
Deadline for registration: 8 April 2016
Fatma Taman, Chair of ISPE Turkey Affiliate, and Buket Hekiman Bayraktar, General Secretary of ISPE Turkey Affiliate, met with future pharmacists in Career Days event of Istanbul Kemerburgaz University. During the visit on March 30th 2016, they contributed to shape future careers of pharmacist candidates by providing information about the working areas of pharmacists through the presentation titled as "Pharmacists in the Pharmaceutical Industry". Students were also guided to access current information for the pharmaceutical industry via ISPEs knowledge resources.
ISPEs Continuous Manufacturing Conference will take place on 20 21 April in Baltimore, Maryland USA. The conference will focus exclusively on Continuous Manufacturing an increasingly popular production strategy with numerous benefits, but also many challenges.
ISPE Turkeys industry gathering around the topic of Data Integrity that was held at The Grand Tarabya on 21 March 2016 was initiated by an introduction of industry gathering series by the Affiliates Chair Fatma Taman. The meeting turned out to be a very interactive one with everyones contributions, following the presentations of Figen Ergin (BTS Information Services) and Timur Kabadayı (Conval Group). The group decided to take the collaborative work further at future workshop platforms.
Industry Gatherings: Data Integrity
21 March 2016
As of 2016, ISPE Turkey Affiliate wish to gather the representatives of our sector in the afternoon meetings that will be organized around the current issues important for our industry.
The first one of our activities in the scope of those Industry Gatherings will be held on March 21, 2016 and will cover the topic of "Data Integrity" which currently has an increasing effect for all of us.
Date: March 21, 2016 - Monday
Time: 17:30 - 19:30
Location: The Grand Tarabya - Rumeli & Hisar Hall
Detailed information regarding the accomplishments and future goals of ISPE Turkey Affiliate can be found in the 10th anniversary video. Click here to see the video.
On the occasion of 10th Anniversary of ISPE Turkey Affiliate, our Chair Fatma Taman attended the live broadcast of Bloomberg HT news bulletin on February 24, 2016. The broadcast can be seen from here.
The news about our seminar "A Holistic Look at Pharmaceutical Industry on the 10th Anniversary of ISPE Turkey" and 10th Anniversary Celebration that were organized on the 3th of December, 2015 at Four Seasons Hotel, Istanbul-Sultanahmet with the attandance of delegates from the pharmaceutical industry, suppliers, academy and Turkish Medicines and Medical Devices Agency officials was published in the January-February 2016 issue of OTC News magazine.
Once again we thank all of our participants who were together with us on this important day and we would like to express our wish to carry on our tradition of conducting groundbreaking projects with which we leave our mark on the future, in the next decades with the contributions of all our stakeholders.
The 2016 ISPE Europe Annual Conference Integrated Technology, Quality and Compliance Strategy for Effective Operations will bring together pharmaceutical, regulatory and technology experts from around the world in Frankfurt in 7-9 March 2016.
The conference will be initiated with executive speeches around the topics of operational excellence, continuous manufacturing and new regulations for pharmaceuticals and biopharmaceuticals and will continue with paralel tracks including GMP updates, facilities of the future, data integrity, risk management and innovative approaches for technical matters.
This two-and-a-half-day, must-attend, education conference will use best practice case studies to explore current technologies, regulatory requirements and will provide delegates with techniques for the evaluation and implementation of cutting-edge technologies. The Conference is aimed at Pharma Development Experts, Quality Management, Quality Assurance, Quality Operations, Quality Control, Quality Systems, Production & Distribution Personnel, Professionals Involved in Manufacturing, Development and Technology Transfer as well as Suppliers and Regulators with interest in new solutions and experiences.
Details about the conference and registration form can be found in the following link: www.ISPE.org/2016-Europe-Annual-Conference
Through the Tulak Tacloban project that ISPE Philippines had supported and ISPE Turkey Affiliate had also contributed after the Typhoon Haiyan hit the Philippines in 2013, 130 schoolchildren finished primary/elementary schooling at mobile schools and these same children are now volunteers in their own community for calamity awareness.
Seminar and 10th Anniversary Celebration / 03 December 2015
ISPE Turkey Affiliates seminar around the theme of A Holistic Look at Pharmaceutical Industry on the 10th Anniversary of ISPE Turkey" and the cocktail was held on December 3, 2015 at Four Seasons Hotel Sultanahmet, İstanbul with the participation of delegates from the pharmaceutical industry, suppliers, academy and Turkish Medicines and Medical Devices Agency officials.
The presentations about Harmonization in GMPs, EU and PIC/S GMP Recent Changes were made by Dr. Vee Revithi, Turkish Medicines and Medical Devices Agency PIC/S Processes by Pharm. Gülşen Yılmaz, Management of Generation Conflicts by Dr. Buket Aksu. Fatma Taman/ Chair of ISPE Turkey Affiliate, Dr. Ünsal Hekiman/ Founder and Honorary Chairman of ISPE Turkey Affiliate, Prof. Dr. Ahmet Araman/ Past Chair of Turkey Affiliate and Dr. Theodora Kourti/ ISPE Senior Vice President for Regulatory Affairs held a speech about the ISPEs activities with regards to the 10th Anniversary of the Affiliate.
While the Affiliates achievements for the past 10 years and the targets for the future were presented through the introductory video; it was also announced that grants to support education set in the name of late Board Member Zehra Gürol will be spread out with the contributions of the Affiliates gold sponspors.
Following the presentation of plaques to our event sponsor BTS and Founder Board Members, our 10th Anniversary was celebrated by cutting the 10th year cake all together and enjoying the cocktail reception with live classical music with the participation of all our guests.
We wish to carry on our tradition of conducting groundbreaking projects with which we leave our mark on the future, in the next decades with the contributions of all our stakeholders...
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